Artefill is the only FDA approved
permanent filler that is on the market today that is a non-re-absorbable
injectable. The FDA approved this filler in November 2006; however Artefill (Artecoll)
has been in use since the late 1980’s, longer than most other cosmetic fillers
on the market. While some doctor’s praise the product for its long lasting
results (which may still be apparent five years after the treatment), others are
wary of injections that are just that – permanent.

Artefill is made up of
Polymethylmethacrylate (PMMA) microspheres suspended in 3.5% denatured bovine
collagen with 0.3% lidocaine. The lidocaine is added to help reduce the
discomfort that is associated with this injection. Polymethylmethacrylate (PMMA)
is a synthetic polymer that has been used with great success in medical
implants, such as bone cement, dentures, and pacemaker covers. In the use of a
dermal filler, it is being used under the brand of ArteFill or Artecoll in
Europe.

This product
was originally produced and distributed
by Artes Medical.

Artes Medical filed for bankruptcy protection last year - and now Cowen
Heathcare Royalty Partners have bought the assets of Artes out of bankruptcy
early this year for an undisclosed price. Artefill is now being
manufactured under a new name - Suneva Medical.

Artefill is the first and only FDA Approved microsphere-enhanced collagen filler
indicated for the nasolabial folds.

The indications of Artefill is for treatment of medium-to-deep wrinkles, folds
and furrows, particularly nasolabial folds; acne scars, lip augmentation, etc. An allergy test is required with this product because of the bovine collagen
component of the injection, which can take 4 weeks before an actual injection of
the product can be made.

Image
courtesy of Artes Medical

The portion of the injection that has
the bovine collagen - is used primarily to provide a smooth suspension and aid
in skin matrix integration. After the injection of Artefill, the bovine collagen
degrades and dissipates over a period of few weeks. During this time, the PMMA
gets encapsulated in the patient’s own collagen which is the body’s natural
response to a foreign material and collagen. Artefill has a very high desirable
result with a low risk of filler migration. There have been cases of the
injection area becoming hard or bumpy, which in fact might be excessive scar
tissue formation. If this does happen, an injection of a steroid may help.

The biggest concern is that the face
continues to change with time, but permanent injectables like Artefill remain
where they were injected, which may not complement the face’s appearance as it
ages. Other problems like lumps (like granulomas) which can occur years after
injection of any permanent material, and would require surgical excision. Some
of these problems are not correctable. However, recent studies show that
patients look better five years after treatment than they did six months
afterward.

Silikon 1000 has become increasingly
more popular over the last few years as patients have longed for permanent
results with lip augmentation. Silikon 1000 is a medical grade pure form of
silicone which is purified

polydimethylsiloxane, which has FDA approval for treatment of retinal detachment
of the eye and is made byAlcon Labs (Fort Worth, Texas).

It currently does not have an approval for cosmetic purposes.
However, Silikon 1000
has been used as filler by cosmetic surgeons and dermatologist for over 30 years
with good lasting results. Although the FDA has not specifically approved the
cosmetic use of the agent, the FDA modernization act of 1997 allows licensed
physicians to use these agents “off label” for other purposes; similar to the
numerous uses for BOTOX before it was approved for cosmetic procedures.

A similar product, Silskin by
Richard-James, Inc. (Peabody, Mass.), received an Investigational Device
Exemption for a clinical trial on facial wrinkles in 2003. Both products are
used off-label as permanent facial fillers.

Silikon 1000 is used commonly for soft
tissue defects or facial augmentation including lips, lines, cheeks, under the
eye area, and for HIV associated facial wasting. This product provides a very
natural looking permanent solution for patients today. The composition of Silikon 1000 comes ready for injection as sterile, clear, colorless silicone
oil. The formulation is supplied and packaged by Alcon in 8.5mL each. No skin
test is required with this filler and there is no downtime.

Silikon 1000 is best injected with
utilizing a “Micro-droplet Technique” and normally the injections are spaced out
within six to eight week interval so that the patient’s own collagen will form a
capsule around the silicone bead to encapsulate it, by stimulating skin cells (known as
fibroblasts) to produce new collagen around each micro-droplet.

Once a
micro-droplet is surrounded, collagen production stops. Through repeated
injections over several months the combination of silicone micro-droplets and
new collagen gradually fills depressions by building soft-tissue by encouraging
the production of new collagen, the skin’s natural structural protein.

With
the silicone bead becoming encapsulated by the patient’s own collagen, it helps
secure the product from not migrating. Micro-droplet technique entails the
injection of several small drops of sterile Silikon 1000 into numerous points
within a desired site. Once injected, the liquid silicone remains chemically
unchanged and is consequently enclosed by the collagen capsule produced by the
patient’s own skin.

Micro-droplet technique minimizes the occurrence of
overcorrection and migration of the silicone that has frequently been seen with
other injection techniques that involves a large volume. The micro-droplet
technique of silicone provides a safe, slowly progressive, and very natural
appearing result in all areas of potential treatment.

Several treatments might be needed in
order to get the desired results, as with less material injected (from .4 to .6
cc) seems to yield fewer complications than larger amounts injected over time.
The results are permanent, so it is better to go slow with Silikon 1000 over
time with multiple treatments so that the physician can manage the results
better. The results are lasting and also instantaneous.

Silicone is often a less painful
treatment than other dermal fillers and patients usually resume their daily
activity, without restrictions, immediately. Like other lip enhancement
treatments, a topical, local, or a nerve block is offered for comfort and may
involve some post-treatment swelling and numbness. These minimal post treatment
symptoms subside within an hour.

There are many advantages of using
Silikon 1000. It is manufactured by Alcon and is FDA approved to be a safe and
effective for use for retina detachment. Having the filler injected with the
micro-droplet technique allows for a gradual natural result and that allows for
fewer chances of migration or granulomas.

The biggest advantage and or
disadvantage of this filler is the fact that the result is long term and more
than likely permanent, so no need for continued injections on a routine basis
with periodic maintenance. The treatment because it is permanent is more
economical than the other fillers. There is slight or mild swelling after the
injection; however this is mainly caused from the dental block that is given
before the injection. The dental block wears off within two hours. Some
physicians have stated that there is 25% less swelling with Silikon 1000 versus
Restylane.

Disadvantages of Silikon 1000:

The disadvantages of Silikon 1000
include abnormal lumps and granulomas might occur. The possibility of migration
is with this product, so it is very important to start out very slow and not to
have a large amount injected at once.

Some of the side effects from the
Silikon 1000 injections are:

idiosyncratic inflammation

bleeding from the injection site

tenderness

swelling

The biggest disadvantage is that it is permanent,
so it is best that you make sure this is what you want. It is recommended that
you start with a temporary filler first, especially if you have never gotten any
facial or lip injections, so that you can see if this is the look you are going
to like. Silikon 1000 is a permanent filler, and there is no going back after it
is injected.

These reactions normally are rare and
can be minimized with appropriate substance volume and injection technique.

If
complications should arise, they are managed with a variety of procedures including: